Arizona Tribune - Unlimited Bio Registers First-in-Class Dual Gene Therapy Trial

A First-of-Its-Kind Dual Gene Therapy Trial

The CALM-AF-AI trial is an open-label, sequential dose-escalation study expected to enroll approximately 12 eligible adult participants aged 45-75 at GARM Clinic in Roatán, Honduras, under applicable ethics oversight.

No prior clinical trial has combined AAV-delivered follistatin - which inhibits myostatin, the body's natural brake on muscle growth - with VEGF plasmid gene therapy, which builds new capillary infrastructure to deliver oxygen and nutrients. Together, the combination potentially will both unlock muscle growth capacity and provide the vascular support to sustain it.

The trial employs a 3+3 dose-escalation design across three cohorts: low-dose AAV-Follistatin monotherapy (5×10¹⁰ vg/kg), high-dose monotherapy (1×10¹¹ vg/kg), and a combination arm with 4.8 mg VEGF plasmid. Rapamycin is co-administered for approximately two months to mitigate immune responses. Beyond primary safety endpoints, the trial tracks an extensive set of functional and biomarker measures through 12 months - including DXA-measured lean mass, bone mineral density, leg press 1RM, grip strength, VO₂max, six-minute walk distance, frailty scales, and serum follistatin/myostatin/IGF-1 levels.

The CALM-AF-A study is designed to generate preliminary safety data and exploratory outcome data for combination gene therapy in eligible study participants.

Conviction and Strategic Positioning

Immortal Dragons first invested in Unlimited Bio in 2024 - reflecting the fund's early conviction that gene therapy represents the most transformative pillar of radical life extension.

The trial is conducted in Próspera ZEDE, a Special Economic Zone offering a forward-thinking regulatory framework for biomedical innovation. For a combinatorial gene therapy trial targeting aging-related muscle decline - which major regulators do not yet formally recognize as a disease - conducting the study with applicable local regulatory and ethics oversight, including IRB review, is essential for the responsible evaluation of this investigational approach. The data generated can inform future regulatory submissions and de-risk subsequent trials in traditional jurisdictions.

"We backed Unlimited Bio because they had the courage to treat aging like what it is: a systems-level engineering problem," said Boyang Wang, Founder of Immortal Dragons. "We believe this research may contribute preliminary data towards our thesis - combinatorial gene therapy for aging and help it move from conviction into clinical reality."

About Immortal Dragons

Immortal Dragons (https://www.id.life/) is a purpose-driven longevity fund headquartered in Singapore. The fund invests in cutting-edge, high-impact technologies and currently supports more than 20 portfolio companies. Beyond conventional investments, the fund advances longevity advocacy through book translation and publishing, translation of longevity leaders' talks, hosting a leading Chinese-language longevity podcast, and providing sponsorships and grants to longevity initiatives and conferences.

For Press Inquiries

Boyang Wang
Founder, Immortal Dragons
[email protected]

SOURCE: Immortal Dragons

View the original press release on ACCESS Newswire

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